Trial · NCT00666536
The Effects of Moderate vs. Aggressive Treatment With Valsartan + Amlodipine on Patients With Hypertension Uncontrolled by Angiotensin-Receptor Blocker (Herein, ARB) Monotherapy
NCT00666536, Phase 4, Completed, Novartis; results first posted 2010-12-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Effects of Moderate vs. Aggressive Treatment With Valsartan + Amlodipine on Patients With Hypertension Uncontrolled by Angiotensin-Receptor Blocker (Herein, ARB) Monotherapy. Trials, record NCT00666536. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00666536
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Effects of Moderate vs. Aggressive Treatment With Valsartan + Amlodipine on Patients With Hypertension Uncontrolled by Angiotensin-Receptor Blocker (Herein, ARB) Monotherapy
- NCT number
- NCT00666536
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 728 participants, actual
- Lead sponsor
- Novartis
- Conditions
- Hypertension
- Interventions
- valsartan and amlodipine, valsartan and amlodipine
- First posted
- 2008-04-25
- Last updated
- 2016-10-27
- Results first posted
- 2010-12-10
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to Week 4 in Mean Sitting Systolic Blood Pressure (MSSBP) | Baseline and Week 4 | |
| Secondary | Percentage of Patients Achieving the Blood Pressure (BP) Goal of < 140/90 mmHg at Weeks 2,4,8 and 12 | Weeks 2, 4, 8 and 12 | |
| Secondary | Change From Baseline to Week 4 in Mean Sitting Diastolic Blood Pressure (MSDBP) | Baseline and Week 4 | |
| Secondary | Change From Baseline to Weeks 2, 8 and 12 in MSSBP | Baseline and Weeks 2, 8 and 12 | |
| Secondary | Change From Baseline to Weeks 2, 8 and 12 in MSDBP | Baseline and Weeks 2, 8 and 12 | |
| Secondary | Percentage of Patients Achieving BP Goal of MSSBP < 140mmHg at Weeks 2, 4, 8 and 12 | Weeks 2, 4, 8 and 12 |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to Week 4 in Mean Sitting Systolic Blood Pressure (MSSBP) | Baseline and Week 4 | Intent to treat (ITT), Last observation carried forward (LOCF) | mmHg | MEAN |
| SECONDARY | Percentage of Patients Achieving the Blood Pressure (BP) Goal of < 140/90 mmHg at Weeks 2,4,8 and 12 | Weeks 2, 4, 8 and 12 | Intent to treat (ITT), Last observation carried forward (LOCF) | Percentage of Patients | NUMBER |
| SECONDARY | Change From Baseline to Week 4 in Mean Sitting Diastolic Blood Pressure (MSDBP) | Baseline and Week 4 | Intent to treat (ITT), Last observation carried forward (LOCF) | mmHg | MEAN |
| SECONDARY | Change From Baseline to Weeks 2, 8 and 12 in MSSBP | Baseline and Weeks 2, 8 and 12 | Intent to treat (ITT), Last observation carried forward (LOCF) | mmHg | MEAN |
| SECONDARY | Change From Baseline to Weeks 2, 8 and 12 in MSDBP | Baseline and Weeks 2, 8 and 12 | Intent to treat (ITT), Last observation carried forward (LOCF) | mmHg | MEAN |
| SECONDARY | Percentage of Patients Achieving BP Goal of MSSBP < 140mmHg at Weeks 2, 4, 8 and 12 | Weeks 2, 4, 8 and 12 | Intent to treat (ITT), Last observation carried forward (LOCF) | Percentage of Patients | NUMBER |
Source ClinicalTrials.gov
Results by group56
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to Week 4 in Mean Sitting Systolic Blood Pressure (MSSBP) | Aggressive Treatment Regimen (5/320 mg to 10/320 mg) | Baseline MSSBP | 163.9 | Standard Deviation 11.85 | mmHg |
| Change From Baseline to Week 4 in Mean Sitting Systolic Blood Pressure (MSSBP) | Moderate Treatment Regimen (5/160 mg) | Baseline MSSBP | 163.3 | Standard Deviation 11.40 | mmHg |
| Change From Baseline to Week 4 in Mean Sitting Systolic Blood Pressure (MSSBP) | Aggressive Treatment Regimen (5/320 mg to 10/320 mg) | Week 4 MSSBP | 140.9 | Standard Deviation 14.61 | mmHg |
| Change From Baseline to Week 4 in Mean Sitting Systolic Blood Pressure (MSSBP) | Moderate Treatment Regimen (5/160 mg) | Week 4 MSSBP | 144.4 | Standard Deviation 14.21 | mmHg |
| Change From Baseline to Week 4 in Mean Sitting Systolic Blood Pressure (MSSBP) | Aggressive Treatment Regimen (5/320 mg to 10/320 mg) | Change From Baseline to Week 4 in MSSBP | -23.0 | Standard Deviation 14.60 | mmHg |
| Change From Baseline to Week 4 in Mean Sitting Systolic Blood Pressure (MSSBP) | Moderate Treatment Regimen (5/160 mg) | Change From Baseline to Week 4 in MSSBP | -18.9 | Standard Deviation 13.92 | mmHg |
| Percentage of Patients Achieving the Blood Pressure (BP) Goal of < 140/90 mmHg at Weeks 2,4,8 and 12 | Aggressive Treatment Regimen (5/320 mg to 10/320 mg) | Week 2 | 25.1 | Percentage of Patients | |
| Percentage of Patients Achieving the Blood Pressure (BP) Goal of < 140/90 mmHg at Weeks 2,4,8 and 12 | Moderate Treatment Regimen (5/160 mg) | Week 2 | 25.8 | Percentage of Patients | |
| Percentage of Patients Achieving the Blood Pressure (BP) Goal of < 140/90 mmHg at Weeks 2,4,8 and 12 | Aggressive Treatment Regimen (5/320 mg to 10/320 mg) | Week 4 | 43.7 | Percentage of Patients | |
| Percentage of Patients Achieving the Blood Pressure (BP) Goal of < 140/90 mmHg at Weeks 2,4,8 and 12 | Moderate Treatment Regimen (5/160 mg) | Week 4 | 31.1 | Percentage of Patients |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Aggressive Treatment Regimen (5/320 mg to 10/320 mg) | 369 | |
| Overall Study | STARTED | Moderate Treatment Regimen (5/160 mg) | 359 | |
| Overall Study | COMPLETED | Aggressive Treatment Regimen (5/320 mg to 10/320 mg) | 336 | |
| Overall Study | COMPLETED | Moderate Treatment Regimen (5/160 mg) | 322 | |
| Overall Study | NOT COMPLETED | Aggressive Treatment Regimen (5/320 mg to 10/320 mg) | 33 | |
| Overall Study | NOT COMPLETED | Moderate Treatment Regimen (5/160 mg) | 37 |
Source ClinicalTrials.gov
Adverse events56
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Oedema peripheral | General disorders | Aggressive Treatment Regimen (5/320 mg to 10/320 mg) | 32 | 369 | |
| other | Oedema peripheral | General disorders | Moderate Treatment Regimen (5/160 mg) | 16 | 359 | |
| other | Dizziness | Nervous system disorders | Aggressive Treatment Regimen (5/320 mg to 10/320 mg) | 19 | 369 | |
| other | Dizziness | Nervous system disorders | Moderate Treatment Regimen (5/160 mg) | 14 | 359 | |
| serious | Angina pectoris | Cardiac disorders | Aggressive Treatment Regimen (5/320 mg to 10/320 mg) | 0 | 369 | |
| serious | Angina pectoris | Cardiac disorders | Moderate Treatment Regimen (5/160 mg) | 2 | 359 | |
| serious | Cardiac arrest | Cardiac disorders | Aggressive Treatment Regimen (5/320 mg to 10/320 mg) | 0 | 369 | |
| serious | Cardiac arrest | Cardiac disorders | Moderate Treatment Regimen (5/160 mg) | 1 | 359 | |
| serious | Cardiac failure congestive | Cardiac disorders | Aggressive Treatment Regimen (5/320 mg to 10/320 mg) | 0 | 369 | |
| serious | Cardiac failure congestive | Cardiac disorders | Moderate Treatment Regimen (5/160 mg) | 1 | 359 |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Aggressive Treatment Regimen (5/320 mg to 10/320 mg) | ||
| Total, all-cause mortality | Moderate Treatment Regimen (5/160 mg) | ||
| Total, other adverse events | Aggressive Treatment Regimen (5/320 mg to 10/320 mg) | 50 | 369 |
| Total, other adverse events | Moderate Treatment Regimen (5/160 mg) | 29 | 359 |
| Total, serious adverse events | Aggressive Treatment Regimen (5/320 mg to 10/320 mg) | 4 | 369 |
| Total, serious adverse events | Moderate Treatment Regimen (5/160 mg) | 10 | 359 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Aggressive Treatment Regimen (5/320 mg to 10/320 mg) vs Moderate Treatment Regimen (5/160 mg): serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00666536
GET https://conductscience.org/api/trials/v1/NCT00666536/results?page=2